Assessing the feasibility of using nasal saline irrigation for managing acute sinusitis
| ISRCTN | ISRCTN13373396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13373396 |
| IRAS number | 253414 |
| Secondary identifying numbers | V1 01/06/2018, 45580, IRAS 253414 |
- Submission date
- 13/02/2019
- Registration date
- 11/06/2019
- Last edited
- 13/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Acute sinus infections are one of the most common infections managed in primary care. Currently, GPs prescribe antibiotics to most patients presenting with sinusitis, the highest of any of the common acute infections presenting in adults, at over 90%. The trouble with prescribing for most people is that we are using antibiotics too much which is causing the bacteria to become resistant, which is likely to lead in the future to serious infections becoming untreatable from ‘superbugs’. Alternatives to the initial management with antibiotics are needed. Previous studies have tried nasal irrigation using salt solution for colds but the studies are small and not conclusive. There have also been studies of nasal irrigation in chronic sinus infections which do show some benefit. A large study in chronic or recurrent sinusitis in primary care showed that most people can learn to do nasal irrigation with simple advice and a short video to show how it is done, find it acceptable and will keep doing it over several weeks. However, there was some evidence that the approach to help people use nasal irrigation could be made more effective, dealing with key barriers or difficulties more effectively. There have been no good studies of saline irrigation in acute sinusitis. The aim of this study is to find out whether using nasal saline irrigation for managing acute sinusitis reduces the use of antibiotics.
Who can participate?
Patients aged 18 - 65 with acute recurrent sinusitis
What does the study involve?
Participants are randomly allocated to either immediate antibiotics (current usual treatment in primary care) or advice to do nasal irrigation for up to 3 weeks with a ‘back-up’ or delayed antibiotic prescription (a prescription that can be used if the sinusitis does not settle). Participants fill out a daily symptom diary to see whether irrigation makes any difference to symptom severity, or to the duration of illness, and whether antibiotics were used. Participants who are happy to have further tests have a swab of the nose.
What are the possible benefits and risks of participating?
This study will provide evidence of recruitment and follow-up rates, and is also likely to provide preliminary evidence about whether antibiotic use is likely to be reduced, in order to provide sufficient evidence for a larger application for a full trial. The benefits are potentially a reduction in antibiotic prescribing/use and help managing symptoms. For nasal irrigation there have been no serious side effects reported, the most common side effects being nasal stinging and sinus discomfort for some patients. If stinging occurs, participants will be advised to reduce the amount of salt in the saline mixture.
Where is the study run from?
1. University of Southampton (UK)
2. University of Bristol (UK)
3. University of Oxford (UK)
When is the study starting and how long is it expected to run for?
August 2018 to June 2021 (updated 04/02/2021, previously: July 2020)
Who is funding the study?
National Institute for Health Research School for Primary Care Research (UK)
Who is the main contact?
1. Tammy Thomas
tet@soton.ac.uk
2. Prof. Paul Little
p.little@soton.ac.uk
Contact information
Public
Primary Care & Population Sciences
University of Southampton
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0003-4383-8586 |
|---|---|
| Phone | +44 (0)2380 591773 |
| tet@soton.ac.uk |
Scientific
Primary Care & Population Sciences
University of Southampton
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| ORCID ID |
0000-0003-3664-1873 |
|---|---|
| Phone | +44 (0)2380 59 1759 |
| p.little@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Saline Nasal Irrigation For acute Sinusitis (SNIFSII) |
| Study acronym | SNIFSII |
| Study objectives | 1. The null hypothesis is that there is no difference between antibiotic utilisation rates between the strategy of providing immediate antibiotics and the alternative strategy of nasal irrigation and a delayed antibiotic prescription. 2. The alternative hypothesis is there are lower antibiotic utilisation rates when using nasal irrigation and a delayed antibiotic prescription compared with providing an immediate antibiotic prescription. |
| Ethics approval(s) | Current ethics approval as of 13/09/2019: 1. Approved 20/06/2019, London-Surrey NRES, Health Research Authority (Whitefriars, Level 3, Block B, HRA, BS1 2NT; +44 (0)207 104 8310; nrescommittee.secoast-surrey@nhs.net), ref: 19/LO/0620 2. Approved 21/06/2019, HRA and Health and Care Research Wales, ref: 19/LO/0620 Previous ethics approval: Approval pending, Surrey NRES, Health Research Authority (Whitefriars, Level 3, Block B, HRA, BS1 2NT; Email: nrescommittee.secoast-surrey@nhs.net), REC ref: 19/LO/0620 |
| Health condition(s) or problem(s) studied | Sinusitis - URTI |
| Intervention | Participants are randomised to either: 1. Immediate antibiotics (current usual treatment in primary care) 2. Advice to do nasal irrigation for up to 3 weeks with a ‘back-up’ or delayed antibiotic prescription (a prescription that can be used if the sinusitis does not settle) Participants will fill out a daily symptom diary to see whether irrigation makes any difference to symptom severity, or to the duration of illness, and whether antibiotics were used. Participants who are happy to have further tests will have a swab of the nose. Sample size: Feasibility estimates: to estimate follow-up rates in each group between 65% and 80%, to be reasonably sure that the follow-up rate is not 50% in each group (i.e.95% confidence intervals of +/- 15%) then 41 per group are needed. The researchers also anticipate that it should be possible for the intervention group to achieve use of antibiotics of around 65% or less. To estimate this proportion with 95% confidence intervals of +/- 15% (i.e. that antibiotic use is 80% or less) 41 per group is also needed. To allow for loss to follow-up more than 100 patients are needed. Feasibility: The previous JAMA trial recruited 238 individuals/4 years with one RA (one centre), but recruitment is currently more challenging. The researchers therefore estimate that with one RA at the coordinating centre and P/T RAs in two other centres will allow them to recruit their target efficiently in 2 winter seasons. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Antibiotic use measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve. 2. Duration of moderately bad symptoms measured using a validated symptom diary; variables (using 7-point Likert scales): nasal blockage, discharge, unpleasant taste/smell, facial pain, pain on bending, impaired activities, generally unwell, sleep disturbance. Completed over four weeks or until symptoms resolve. |
| Secondary outcome measures | 1. Symptom duration until little/no problem, measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve 2. Mean symptom score measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve 3. Development of new/worsening symptoms measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve 4. Health-related quality of life measured using EQ5D, completed over four weeks or until symptoms resolve 5. Reconsultations/resource use during the next month measured using patient note reviews conducted by staff at the surgeries |
| Overall study start date | 01/08/2018 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 108 |
| Key inclusion criteria | The researchers pragmatically define acute sinusitis as having sinus discomfort and at least 2 other symptoms (2 of: patient-reported nasal obstruction, patient-reported purulent nasal discharge, or pus seen in the nasal cavity on inspection by the clinician). They do not propose using prior duration (e.g. the requirement for at least 7 days without improvement in the Canadian guidelines) since there is no good evidence for a particular cut-off, and their aim is to help people who are currently being treatment with antibiotics for sinusitis, many of whom present with 7 days. |
| Key exclusion criteria | 1. Inability to complete outcomes (reduced capacity: dementia, severe uncontrolled mental illness; terminal illness etc) 2. Head/neck cancer 3. HIV 4. Immune-suppressive treatment 5. Cystic fibrosis 6. Pregnancy/breastfeeding 7. Other nasal disorders e.g. polyps; poor gag/swallow reflexes |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 31/05/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Faculty of Medicine
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Room 1.01
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Sponsor information
University/education
Head of IP, Contracts and Policy
Research & Innovation Services
Highfield Campus
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)2380595058 |
|---|---|
| D.Galpin@soton.ac.uk | |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Paul Little (p.little @soton.ac.uk). Type of data: quantitative trial data. When the data will become available and for how long: at the end of the feasibility study so probably by June 2021. If a reasonable proposal is made to the PI (Prof. Little) the data will be made available; in the unlikely event of a request being declined the Board of the NIHR SPCR will be the arbiter. All participants were consented, data will be anonymised, no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1.2 | 09/05/2019 | 16/09/2019 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13373396_Protocol_V1.2_09May2019.pdf
- Uploaded 16/09/2019
Editorial Notes
13/07/2021: The intention to publish date was changed from 30/06/2022 to 31/07/2022.
07/07/2021: The following changes were made to the trial record:
1. The scientific title was changed from "SaliNe Irrigation For recurrent Sinusitis (SNIFSII)" to "Saline Nasal Irrigation For acute Sinusitis (SNIFSII)".
2. The intention to publish date was changed from 31/07/2021 to 30/06/2022.
04/02/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2021 to 30/06/2021.
2. The plain English summary was updated to reflect these changes.
22/06/2020: The overall trial end date has been changed from 31/07/2020 to 31/03/2021.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
16/09/2019: Uploaded protocol Version 1.2 09 May 2019 (not peer reviewed).
13/09/2019: The following changes have been made:
1. The ethics approval has been updated.
2. The protocol numbers 45580 and IRAS 253414 have been added from the ethics approval documents.
28/05/2019: Trial's existence confirmed by the NIHR.
